Kornimate/medical-research-clean huggingface dataset:
trial combining pembrolizumab and cesium 131 brachytherapy with salvage surgery in hnscc

Conditions: HNSCC

Summary: to study perioperative pd-1 inhibitor and cesium-131 interstitial brachytherapy in patients with locally recurrent hnscc eligible for salvage surgery.

this study is a non-randomized, single-arm, multi-institutional phase 1b/ii study including patients with locally recurrent head and neck cancer eligible for resection. patients who are identified to be eligible for surgical resection will be screened and consented to receive one 200mg iv dose of pembrolizumab followed by salvage surgery. at the time of surgery, they will have cesium131 seeds implanted. two to six weeks after surgery, subjects will be started on 200 mg iv of pembrolizumab to be continued every 3 weeks for 6 months. the phase 1b part will enroll 3 patients for a safety run-in, followed by the phase 2 part if no dlts are seen in these 3 patients. phase 2 will be used to estimate the 2-year dfs in comparison to a benchmark selected based on a historical control. for correlative studies, archived tissue and surgical specimen will be evaluated by h\&e and ihc for immune phenotype. blood samples will also be collected as shown in schema above for correlative studies (blood will be collected for correlatives and biomarkers before and after the first of pembrolizumab, before starting adjuvant pembrolizumab and at completion of 6 month course of adjuvant pembrolizumab). patients will be followed approximately every 3 weeks during treatment for the first 6 months, then monthly for 3 months following treatment and then every 3 months thereafter for 24 months for disease free survival (dfs) and overall survival (os).

Eligibility criteria:
inclusion criteria: * locally recurrent hnscc and be eligible for salvage surgery * if patient received radiation therapy in the past, they should have recovered from the acute toxicity to \<grade 1 * tumor needs to be deemed resectable exclusion criteria: * exposed carotid artery preoperatively requiring sacrifice or bypass intra-operatively * patients with active pharyngo-cutaneous * patients with more than one site of distant metastatic disease * prior immune-based anticancer therapy within last six months
oxytocin in opiate dependence: a pilot study of the effects of intranasal oxytocin on emotional processes and stress responses in patients with opiate dependence

Conditions: Opiate Dependence

Summary: opiate dependence is a serious problem, and oxytocin has many properties which make it attractive as a treatment for this type of substance dependence. this experiment will test the effects of oxytocin on a variety of brain-based processes in patients with opiate dependence. the investigators hypothesize that intranasal oxytocin in these conditions will enhance emotional processing and will have beneficial effects on stress responses in opiate-dependent patients.


Eligibility criteria:
inclusion criteria: * adult men 18 years or older * meet dsm-iv criteria for opiate dependence, and no other active substance dependence disorder save nicotine dependence * clinically stable, and low risk for suicide as determined by principal investigator and screening questionnaire * abstinent from non-prescribed opiate use for at least two weeks from baseline 1 and free from opiate withdrawal symptoms. if on agonist therapy, dose must be stable for 2 weeks before study visit. * must be able to use nasal spray * negative salivary drug screen, save for opiates exclusion criteria: * any active medical condition that in the opinion of the investigator will interfere with the objectives of the study * any active, severe mental illness, neurological disorder, including schizophrenia, autism, asperger's syndrome * are unsuitable in any way to participate in this study, in the opinion of the investigator * hospitalizations due to complications of an axis 1 disorder for the past 12 months, excluding drug or alcohol rehabilitation * any clinically significant chronic pain condition, as determined by the principal investigator * positive salivary drug screen at the time of the visit, for any substance other than opiates or another prescribed medication

Keywords: oxytocin
motivators and barriers for physical activity in patients with minor stroke

Conditions: Stroke, Ischemic

Summary: the aim of this study is to investigate motivators and barriers for physical activity in patients discharged from hospital for a minor stroke or tia. the study has a qualitative research design and will be conducted by focus group interviews.

little is known about motivators and barriers for physical activity after hospital discharge for patients with a minor stroke or tia. these patients have few and temporary symptoms and are therefore discharged early from the hospital or seen in a outpatient tia clinic. standard treatment are preventive medication and advice on self-managed lifestyle changes. occurrence of one ischemic stroke or tia predisposes to further ischemic strokes and patients are at risk of developing cognitive deficits or vascular dementia over time unless multiple preventive measures are taken including physical activity. the purpose is to investigate motivators and barriers for physical activity after hospital discharge by focus-group interviewing this potential fragile group of patients. the research team want to facilitate the patients to be physically active and thereby prevent a recurrent stroke and slow the progression of vascular diseases.

Eligibility criteria:
inclusion criteria: * patients with ischemic stroke or transient ischemic attack (tia) without the need of a re-habilitation plan, but needs an exercise plan in order to prevent a recurrent stroke * patients who have participated in ≤ 1 hour of vigorous intensity activity on weekly basis within the last 3 months * patients able to speak, read, and understand danish * patients ≥ 18 years of age and able to give informed consent exclusion criteria: * patients with previous large artery stroke with sequelae preventing aerobic exercise in groups * symptoms or comorbidities preventing aerobic exercise in groups * dyspnoea caused by heart or lung diseases (e.g. chronic obstructive pulmonary disease (copd)) * aphasia or dementia interfering with participation in aerobic groups exercise * patients with intermittent claudication/vascular claudication

Keywords: physical activity motivators for physical activity barriers for physical activity secondary stroke prevention
efficacy and safety of umbilical cord mesenchymal stem cells transplantation in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes; Mesenchymal Stem Cells

Summary: this study is a 24-week single-center, randomized, double-blind, placebo-controlled trial. the trial includes a 3-week early screening and lifestyle education period, 6-week treatment period, and 18-week follow-up period. chinese type 2 diabetic subjects receiving traditional hypoglycemic treatment were randomly assigned to umbilical cord mesenchymal stem cell or placebo infusion therapy to observe the efficacy and safety of umbilical cord mesenchymal stem cell infusion therapy.

this study is a 24-week single-center, randomized, double-blind, placebo-controlled trial. the trial includes a 3-week early screening and lifestyle education period, 6-week treatment period, and 18-week follow-up period. chinese type 2 diabetic subjects receiving traditional hypoglycemic treatment（including insulin） were randomly assigned to umbilical cord mesenchymal stem cell or placebo infusion therapy to observe the efficacy and safety of umbilical cord mesenchymal stem cell infusion therapy.

Eligibility criteria:
inclusion criteria: 1. type 2 diabetes； 2. the course of diabetes is 5-15 years; 3. 20kg/m2≤body mass index (bmi)≤30 kg /m2； 4. 7.5% ≤hba1c≤10%； 5. insulin dose and other oral antidiabetic drugs doses should be stable over the 3 months prior to randomization. exclusion criteria: 1. heavy allergic constitution or an allergy to any component used in cell culture. 2. being treated with drug (glucocorticoids，tricyclic antidepressive agents,etc.) affect the metabolism of glucose in the past 1 month; 3. other causes of diabetes; 4. all kinds of acute complications such as diabetic ketoacidosis and non-ketohyperosmotic syndrome were screened in the past 6 months; 5. having evidence of ongoing or frequent/severe hypoglycemia in the past 6 months; 6. severe cardiovascular and cerebral events：occurrence of heart failure nyha classification iii or iv, myocardial infarction, cerebral infarction, cerebral hemorrhage within 6 months before the observation period; 7. patients with abnormal liver and kidney function: ast and alt exceeding 2.5 times of the normal upper limit, and serum creatinine exceeding 1.5 mg/dl for men, exceeding 1.4 mg/dl for women; 8. positive results of hbsag、anti-hcv、hiv or syphilis; 9. patients suffering from other serious systemic diseases (such as malignancy, central nervous system,cardiovascular system, blood system, digestive system,endocrine system,respiratory system, genitourinary system, immune system and); 10. ongoing pregnancy or absence of effective contraception in women with childbearing potential; 11. patients who had received other stem cell therapy before screening.

Keywords: umbilical cord mesenchymal stem cells type 2 diabetes
paradoxical response to chest wall loading in mechanically ventilated patients

Conditions: ARDS; COVID-19; Mechanical Ventilation Pressure High; Ventilator-Induced Lung Injury

Summary: the purposes of our study are to: 1) determine the incidence of paradoxical response to chest wall loading in mechanically ventilated patients; 2) identify sub-populations in which it is most likely to occur (e.g., severe ards); and 3) standard the bedside procedure for demonstrating this physiology.

mechanical ventilation can be a life-saving intervention for patients with respiratory failure, but the acutely injured lung is vulnerable to further damage if positive pressure ventilation is not employed judiciously. "lung protective ventilation" encompasses a group of practices intended to minimize ventilator-induced lung injury (vili) and includes the delivery of low tidal volumes (to minimize dynamic lung strain) and the prevention of injuriously high airway pressures (to minimize lung stress). the prone position, which compresses (or "loads") the chest wall, more evenly distributes volume and pressure, mitigates the damaging effects of stress/strain, and improves clinical outcomes in patients with severe respiratory failure from adult respiratory distress syndrome (ards). chest wall loading would not be expected to produce these beneficial effects in the supine position-quite the opposite; it usually results in net volume loss and higher airway pressures in response to an unchanging tidal volume. a paradoxical response to chest wall loading, leading to decreased airway pressures, however, was recently reported in a group of patients with advanced lung disease secondary to covid-19. in this cohort, a paradoxical decrease in airway pressures was elicited during a brief period of manual compression of the abdomen. this maneuver, which is non-invasive, free of cost, and gives real-time information, may have important diagnostic (and potentially therapeutic) implications for ventilator management in patients with respiratory failure.

Eligibility criteria:
inclusion criteria: non-surgical patients admitted to the icu at regions hospital (st. paul, mn) or methodist hospital (st. louis park, mn), receiving mechanical ventilation for any reason, and breathe passively during mechanical ventilation exclusion criteria: 1. age \< 18 years old 2. pregnancy at the time of their inclusionary hospitalization 3. recent (\< 30 days) abdominal or chest wall surgery (including spine) 4. recent (\< 30 days) abdominal or chest wall trauma (including spine) 5. traumatic brain injury, intracranial bleed, or recent neurologic surgery 6. family member or representative not available to provide informed consent 7. not passive while receiving mechanical ventilation support 8. hemodynamic instability
bioequivalency study of mycophenolate mofetil 500 mg tablets under fed conditions

Conditions: Prophylaxis of Organ Rejection

Summary: the objective of this study was to prove the bioequivalence of mycophenolate mofetil 500 mg tablets under fed conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. treatment with known enzyme altering drugs. history of allergic or adverse response to mycophenolate mofetil or any comparable or similar product.
study of transaxillary robotic thyroidectomy versus standard open thyroidectomy: prospective, comparative single-center study

Conditions: Carpal Tunnel Surgery

Summary: the aim of our study is to evaluate the two surgical approaches, standard thyroidectomy and robotic thyroidectomy, in terms of postoperative pain management, scar quality, quality of life, as well as the occurrence of postoperative complications (hypocalcemia, compressive cervical hematoma and nerve stimulation)


Eligibility criteria:
inclusion criteria: * subject aged over 20 years * referred for a thyroidectomy (total or partial) * absence of participation in another clinical study * subject affiliated to a social security scheme or beneficiary of such a scheme * accepts the completion of the various study questionnaires exclusion criteria: * patient under 20 years of age. * patients who have undergone combined radical cervical lymph node dissection * patient with a postoperative wound problem * patient with an underlying systemic disease that may influence the wound healing process * unable to undergo medical follow-up for the study.
tap to "tap", pathobiome associates health care

Conditions: Otorhinolaryngologic Diseases

Summary: the bacteria live in community and in some cases it is the combination of several microorganisms that facilitates transmission and pathogenicity. the concept of pathobiome follows from this finding. investigators hypothesize that the microbial community water point is a pathobiome influencing installation and transmission of pathogens associated with care

goals : key: to study the impact of bacterial communities on the risk of transmission of waterborne pathogenic bacterium pseudomonas aeruginosa in patients hospitalized from a contaminated water source by this bacterium. secondary: 1. assess the role of communities on installing the water points in p. aeruginosa by comparing contaminated and uncontaminated water sources. 2. to evaluate the effect of the quality of water and the conditions of use of water points network on the composition of bacterial communities associated or not with p. aeruginosa. experimental study conducted from 6 points of water, contaminated deliberately experimental backs onto the project to assess conventional and alternative measures decontamination network and water points

Eligibility criteria:
inclusion criteria: * patients in the otorhinolaryngology department exclusion criteria: * immunocompromised patients * patient opposition to enter the research protocol
the influence factors of ovarian response in pcos patients with ivf-et treatment

Conditions: Polycystic Ovary Syndrome

Summary: the purpose of this study is to explore the factors which affect ovarian response of pcos patients with ivf-et treatment, in order to provide predictive clinical index for the outcome of ivf-et treatment in pcos patients. after figuring out the controllable factors, researchers would be able to educate pcos patients and improve the success rate while reducing the incidence of complications during the treatment at the same time.

statistics of pcos patients like age, bmi index and others would be collected. through distributing questionnaires and query of past cases and collecting data recorded during the ovulation process like monitoring fluctuations in blood and ultrasonic monitoring results, researchers obtain the risk factors of the occurence of ovarian hyperstimulation syndrome(ohss) in ivf-et treatment in pcos patients and set up an ohss prediction model, choose controllable factors in order to make up guidance and have intervention on patients with pcos accordingly. the investigators expect this could improve the success rate of ivf-et treatment in patients with pcos, provide clues and assist to reduce the risk of the therapy.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of pcos * long schedule time of luteal phase * available to trace * normal prolactin level with contraceptive treatment in recent 3 months exclusion criteria: * unwilling to participate
dna-based testing in bal of lung transplant recipients with suspected non-viral lower respiratory tract infection

Conditions: Lower Respiratory Tract and Lung Infections

Summary: lung transplantation (ltx) , dna-based testing. performance of dna-based testing of bacterial and fungal pathogens in comparison to standard testing. experimental intervention: dna-based testing of bal fluid.

cohen's kappa of any pathogen isolation by dna-based testing vs. standard cultures in comparison to the final diagnosis of non-viral lower respiratory tract infection.

Eligibility criteria:
inclusion criteria: * patients after lung transplantation (single, double or combined) * suspicion of non-viral lower respiratory tract infection as defined by at least 2 out of * new onset of malaise * new or progressive pulmonary infiltrate * hypoxemia (spo2/sao2 \<92% or need for oxygen) * temperature of 38 o c or above within 7 days * purulent (yellow or greenish) sputum * crp of 30 mg/l or above * pct of 0,5 µg/l or above exclusion criteria: * no informed consent
a randomized control trial for preventative scar management

Conditions: Hypertrophic Scarring

Summary: the study's objective is to compare the global scar outcomes in those treated with silicone only therapy (sot) versus silicone pressure garment therapy (spgt) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury.

the goals of this study are to: 1. examine the difference between patient scores on the posas scale in those randomized to silicone pressure garment therapy (spgt) versus silicone only therapy (sot) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury at baseline, 8, 16, and 24 weeks. 2. examine the difference between observer scores on the posas scale in those randomized to silicone pressure garment therapy (spgt) versus silicone only therapy (sot) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury at baseline, 8, 16, and 24 weeks. 3. examine the difference between vancouver scale in those randomized to silicone pressure garment therapy (spgt) versus silicone only therapy (sot) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury at baseline, 8, 16, and 24 weeks. 4. examine the need for surgical intervention in those randomized to silicone pressure garment therapy (spgt) versus silicone only therapy (sot) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury.

Eligibility criteria:
inclusion criteria: * patients who have undergone surgery within one month prior to enrollment * patient must have a split-thickness or full thickness skin graft with extremity involvement secondary to a traumatic skin injury (burn, laceration, avulsion or de-gloving type injury) that has healed (based on clinician assessment of wound healing) * patients with comorbid conditions * patients must be referred to and attend scar management clinic at dcmc exclusion criteria: * patients with concave scars at the site of the skin graft * patients with skin graft scars larger than 4x7 inches * patients with presence of current skin infection or history of dermatological condition such as eczema * patients with skin grafts only on parts of the body other than extremities * patients with reported silicone allergies

Keywords: preventative scar management skin grafts silicone therapy silicone pressure garment therapy
exercise training for smoking students

Conditions: Nicotine Dependence; Smoking; Physical Inactivity; Depression

Summary: smoking can damage lung functions as a result of high carbon monoxide and low hemoglobin oxygen carrying capacity in the blood. smoking between young people continues to increase, which can cause respiratory function problems and lung diseases at an early age. in the studies, it has been seen that smoking may reduce the oppression and exercise ability.

students who voluntarily accept participation in the study and sign the illuminated consent form, pulmonary status, gender, age, and body mass index to question data such as demographic data form, nicotine dependence levels fagerstrom nicotine dependence scale, international physical activity scale (ipaq), and beck depression scale will be used. then the respiratory function test will be evaluated with respiratory parameters and a 6-minute walking test. all evaluations made at the beginning of the study will be applied three times after the 8-week exercise program and the first month of control. first of all, the students will be grouped according to nicotine dependence levels, and exercise groups will be randomized according to each addiction level. groups to be formed: group 1: face-to-face exercise group; group 2: online (telesağlık) exercise group; group 3: control group.

Eligibility criteria:
inclusion criteria: * signing the illuminated consent form, * to be smoking at least 1 cigarette a day for the last 6 months, * not having orthopedic or neurological findings that can prevent the exercises included in the study, * to have low-medium level physical activity level, * not to have any lower respiratory infection in the last 3 months. exclusion criteria: * to the exercise sessions to be held on time and not to arrive regularly

Keywords: resistance exercise respiratory exercise nicotine addiction respiratory function test telehealth